- Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices. Conduct statistical analysis of the date to support the reports.
- Generation and implementation of change controls and engineering notices (ECO).
- Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
- Complete/conduct assigned Non-Conformance and CAPA investigations and prepare investigation reports.
- Troubleshooting equipment/processes that do not perform as intended during validation runs.
- Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
- Recommend process/quality improvements as part of validation runs.
- Participate as required in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.
- Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
- Work on project teams with other internal departments, external vendors, and customers as required.
- Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
- Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
- Performs other related duties as necessary.
Qualifications used for the requisition:
- Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
- Knowledge of Medical Devices Validation principles – EO Sterilization,
- Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
- Knowledge in Organizational Excellence and Lean/Six Sigma
- Strong Project Management skills.
- Ability to lead teams through complex projects and provide departmental technical leadership.
- Must have excellent communication skills and a strong track record of working cross-functionally.
- Must have demonstrated ability to think strategically.
- Teamwork oriented and self-starter
- Fully bilingual.
Education and/or experience:
- BS in Engineering, preferably Biomedical, Chemical, Mechanical, Industrial or sciences related field.
- Experience in medical devices validation; EO Sterilization, manufacturing equipment/processes required
- Lean/Six Sigma Green or Black Belt Certification is a plus.
- Minimum of 5 - 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in a validation position
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posting ID: 606204483Posted: 2021-02-26